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enGene Therapeutics Inc. 8K

0001193125-26-384380

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enGene Therapeutics Inc. announced third quarter 2026 results and a business update centered on progressing its lead NMIBC gene therapy detalimogene toward a planned BLA filing in 4Q 2026 while maintaining a strong cash position and transitioning board leadership.

On September 8, 2026, enGene Therapeutics Inc. reported its financial results for the third quarter ended July 31, 2026, and provided a business update highlighting progress of its lead gene therapy candidate detalimogene voraplasmid in the Phase 2 LEGEND trial for BCG‑unresponsive non‑muscle invasive bladder cancer, including previously reported pivotal cohort complete response data, plans for a data update and a pre‑BLA meeting with the FDA in the fourth quarter of 2026, the planned initiation of a BLA filing for detalimogene in the same quarter, advancement of a surfactant plus detalimogene cohort following a successful safety run‑in, precommercial market‑education webinars, a board leadership transition with Michael Heffernan becoming Chairman, and a financial position featuring $266.3 million in cash, cash equivalents and marketable securities and a quarterly net loss of $32.5 million.

Filing Facts

CIK
1980845
Ticker
-
Form
8K
Source Type
sec
Accession
0001193125-26-384380
Alert Tier
7
enGene Therapeutics Inc. 8K | ATTN